# US 12,214,114 B2 · Flow synchronization devices, methods, and systems

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- Number: US 12,214,114 B2
- Document ID: US12214114B2
- Status: Granted
- Kind: B2
- Application number: 17/612,905
- Filed: 2020-05-22
- Published: 2022-11-17
- Granted: 2025-02-04
- Earliest claimed: 2019-05-23
- Assignees: NxStage Medical, Inc.
- Applicants: NxStage Medical, Inc.
- Inventors: Jerome James
- Web page: https://patentgrep.com/patent/US12214114B2

## CPC

- A61M 1/341: {by measuring the filtrate rate or volume}
- A61M 1/1603: {Regulation parameters}
- A61M 1/3441: {Substitution rate control as a function of the ultrafiltration rate}
- A61M 1/3431: {upstream of the filter}
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A parameter for controlling an inlet pump speed in a hemofiltration system is derived from fitting a line to multiple data points of pressure versus pump speed. The pressure is measured in a channel connecting an inlet pump to an outlet pump. First, the inlet pump operates and the pressure is sampled until it is stabilized, then the inlet pump speed is increased and pressure is measured to obtain a data point. Subsequently the inlet pump speed is decreased and pressure is measured to obtain another data point. A line is fit through the data points to obtain the parameter.

## Claims

### Claim 1

A method of controlling pumps, that include an inlet peristaltic pump and an outlet peristaltic pump, in a hemofiltration system, comprising:
connecting the inlet peristaltic pump, by a connecting channel, in series with the outlet peristaltic pump;
pumping with the inlet peristaltic pump and the outlet peristaltic pump while measuring a pressure within the connecting channel between the inlet peristaltic pump and the outlet peristaltic pump until the measured pressure stabilizes within a predefined time interval;
varying an inlet peristaltic pump speed until the inlet peristaltic pump speed reaches a first value at which the pressure reaches a predefined target pressure P1;
increasing only the inlet peristaltic pump speed to a second value greater than the first value and recording a pressure P2 within the connecting channel corresponding to the second value of the inlet peristaltic pump speed;
after the increasing, decreasing only the inlet peristaltic pump speed to a third value smaller than the first value and recording a pressure P3 within the connecting channel corresponding to the third value of the inlet peristaltic pump speed;
fitting a line to at least points defined by the predefined target pressure P1 and the first value of the inlet peristaltic pump speed, pressure P2 and the second value of the inlet peristaltic pump speed, and pressure P3 and the third value of the inlet peristaltic pump speed;
deriving a parameter Icomp from a slope of the fitted line; and
using the parameter Icomp to control the inlet peristaltic pump speed.

### Claim 2 (depends on 1)

The method of claim 1, wherein the inlet peristaltic pump is configured to pump replacement fluid into a blood line.

### Claim 3 (depends on 1)

The method of claim 1, wherein the outlet peristaltic pump is configured to withdraw waste fluid from a hemofilter.

### Claim 4 (depends on 3)

The method of claim 3, wherein the predefined target pressure is obtained by measuring the pressure in a waste compartment when there is no flow across a membrane of the hemofilter and while blood is flowing such that a predefined average pressure exists on a blood side of the hemofilter.

### Claim 5 (depends on 4)

The method of claim 4, wherein the predefined average pressure on the blood side is measured at a selected blood pumping speed.

### Claim 6

A system for controlling flow in a fluid circuit, comprising:
a hemofiltration machine with fluid circuit having blood and non-blood portions, a controller, a waste pump, a dialysate pump, and a treatment fluid pump connected to a hemodiafilter, a pressure sensor at an inlet of the waste pump, and flow controllers permitting selective interconnection of the blood and non-blood portions;
the controller controlling a net ultrafiltration, during a treatment mode, by independently regulating a speed of the waste pump that draws fluid from the hemodiafilter, a speed of a replacement fluid pump that pumps replacement fluid into the blood portion, and a speed of the dialysate pump that pumps dialysate into the hemodiafilter;
the controller controlling the pumps to implement first and second synchronization modes and the treatment mode;
in the first synchronization mode, the controller detecting a target pressure at an inlet of the waste pump while flowing blood through the hemodiafilter and while blocking flow through the replacement fluid and waste pumps;
subsequently, in the first synchronization mode, the controller controlling pumping of dialysate through the hemodiafilter using the dialysate pump and the waste pump and controlling the waste pump speed to establish a predetermined dialysate flow rate, controlling the dialysate pump speed to determine a synchronized dialysate pump speed that maintains the waste pump inlet pressure at said target pressure;
subsequently, in the second synchronization mode, the controller connecting the replacement fluid pump and the waste pump directly in series and, while flowing replacement fluid between them and controlling the waste pump speed to a first value that establishes a predetermined hemofiltration rate, controlling the replacement fluid pump speed to determine a synchronized replacement fluid pump speed that maintains the waste pump inlet pressure at said target pressure, and perturbing only the replacement fluid pump speed to a higher speed than the first value and to a lower speed than the first value and calculating a calibration parameter based on pressures measured at the higher speed and at the lower speed;
subsequently, in the treatment mode, the controller connecting the replacement fluid pump to pump replacement fluid into the blood portion at said synchronized replacement fluid pump speed, connect said dialysate pump to pump dialysate into said hemodiafilter at said synchronized dialysate pump speed, and to connect said waste pump to draw waste fluid from the hemodiafilter at a rate responsive to the predetermined dialysate flow rate and the predetermined hemofiltration rate.

### Claim 7 (depends on 6)

The system of claim 6, wherein, in the treatment mode, the waste pump is controlled to draw the waste fluid from the hemodiafilter at a rate equal to a sum of the predetermined dialysate flow rate and the predetermined hemofiltration rate.